Clinical Efficacy of Biofeedback Therapy – Efficacious for Attention Deficit Hyperactivity Disorder (ADHD). Clinically significant improvement on behavioral measures.
*** Also the results support the hypothesis that Biofeedback Therapy is effective in improving both the verbal and full-scale IQ scores in children. Biofeedback therapy lasted approximately 30 to 45 minutes and was conducted weekly for seven months. The average number of sessions per student was 28.
a. In a comparison with a no-treatment control group, alternative treatment group, or sham (placebo) control utilizing randomized assignment, the investigational treatment is shown to be statistically significantly superior to the control condition, or the investigational treatment is equivalent to a
treatment of established efficacy in a study with sufficient power to detect moderate differences,
b. The studies have been conducted with a population treated for a specific problem, for whom inclusion criteria are delineated in a reliable, operationally defined manner, and
c. The study used valid and clearly specified outcome measures related to the problem being treated,
d. The data are subjected to appropriate data analysis, and
e. The diagnostic and treatment variables and procedures are clearly defined in a manner that permits replication of the study by independent researchers, and f. The superiority or equivalence of the investigational treatment has been shown in at least two independent research settings.
Clinically significant improvements of Attention Deficit Hyperactivity Disorder (ADHD)
A variety of techniques such as slow cortical potentials, hemoencephalographic feedback, and cranial electrotherapy for treatment of ADHD have recently been reported. However, the majority of biofeedback studies have utilized EEG biofeedback; therefore, this technique will be the only one used to evaluate the efficacy for this disorder. The other techniques will be briefly presented at the end of this section.Even studies using EEG biofeedback to treat ADHD are difficult to summarize because they use a variety of training protocols and a variety of outcome measures. However, because the majority of studies used protocols that were directed toward reducing the abundance of slow frequencies while increasing the abundance of fast frequencies, some generalizations across studies are warranted. Numerous case studies; a multitude of treatment-only studies; some treatment compared to wait-list or no-treatment controls; and a few random-assignment, treatment-comparison groups have been reported. There are also a few review articles. These review articles should be evaluated with caution as they tend to have many of the same studies incorporated within their results. While the majority of the review articles conclude EEG biofeedback is effective when compared to no treatment, a placebo, or another treatment group, some of the reviews find fault with either the methodologies or outcome measurements of some studies.
Earlier uncontrolled studies using neurofeedback (NF) contingent on decreasing slow wave activity and increasing fast wave activity show persons with ADHD improved in symptoms, intelligence score, and academic performance (Grin’-Yatsenko et al. 2001; Lubar, Swartwood, Swartwood, & O’Donnell, 1995; Thompson & Thompson, 1998).
In one study, only those individuals who significantly reduced theta over the training sessions showed a 12-point increase in Wisconsin Intelligent scale for children-revised (WISC-R) IQ, improved Test of Variables of Attention (TOVA), and Attention Deficit Disorders Evaluation Scale (ADDES) rating score (Lubar et al. 1995). One large multicenter study (1,089 participants, aged five to 67 years) showed sensorimotor-beta EEG biofeedback training led to significant improvement in attentiveness, impulse control, and response variability as measured on the TOVA (Kaiser & Othmer, 2000) in those with moderate pretraining deficits.
A few early controlled studies compared EEG biofeedback to other treatments. The first of these was a study with four hyperkinetic children under six conditions: 1) no drug, 2) drug only, 3) drug and sensory motor rhythm (SMR) training, 4) drug and SMR reversal training, 5) drug and SMR training II, and 6) no drug and SMR training (Shouse & Lubar, 1979). Combining medication and SMR training resulted in substantial improvements in behavioral indices that exceeded the effects of drugs alone and were sustained with SMR training after medication was withdrawn. These changes were absent in the one highly distractible child who failed to acquire the SMR task.
In a study of 16 elementary-age children who were randomly assigned to conditions comparing EEG biofeedback to a waiting-list control, Carmody, Radvanski, Wadhwani, Sabo, and Vergara (2001) reported conflicting outcomes as measured by the TOVA and teacher reports. They found improvements in the reduction of errors of commission, anticipation, and attention.
Another small (n=18) controlled study showed increased intelligence scores and reduced inattentive behaviors as rated by parents in comparison to the waiting-list control (Linden, Habib, & Radojevic, 1996). Another study by Rossiter and La Vaque (1995) comparing EEG biofeedback to stimulant medication demonstrated both groups improved on measures of inattention, impulsivity, information processing, and variability as measured by the TOVA. Since 2002, a number of studies on the effectiveness of EEG biofeedback have been published, and they are presented briefly below. Some are outcome studies, and where available, the methodologies and outcome measures are presented while others are reviews. Some studies were not based on slow-wave reduction and fast-wave enhancement, so their techniques need to be considered separately from the typical EEG biofeedback protocol.
In a study of EEG biofeedback and stimulant medication effects, Fuchs, Birbaumer, Lutzenberger, Gruzelier, and Kaiser (2003) compared the effects of a three-month EEG biofeedback program providing reinforcement contingent on the production of cortical SMR (12-15 Hz) and beta-l
activity (15-18 Hz) with stimulant medication. Participants were aged eight to 12 years; 22 were assigned to the EEG biofeedback group and 12 to the methylphenidate group according to their parents’ preference. Both EEG biofeedback and methylphenidate were associated with improvements on all subscales of the TOVA and on the speed and accuracy measures of the d2 Attention Endurance Test.
Furthermore, behaviors related to the disorder were rated as significantly reduced in both groups by both teachers and parents on the IOWA-Conners Behavior Rating Scale.
Another study relating stimulant medication to EEG biofeedback training reported 16 of 24 patients taking medications were able to lower their dose or discontinue medication totally after 30 sessions of EEG biofeedback (Alhambra, Fowler, & Alhambra, 1995). Finally, Monastra, Monastra, and George (2002) studied one hundred children with ADHD receiving Ritalin, parent counseling, and academic support at school. Based on parent preference, 50 children also received EEG biofeedback. While children improved on the TOVA and an ADHD evaluation scale while taking Ritalin, only those who had EEG biofeedback sustained these improvements without Ritalin.
Pryjmachuk (2003) presented a review of randomized controlled trials (RCTs) evaluating treatment for ≥ 12 weeks in children with ADHD. Articles were selected if they were full reports published in any language in peer-reviewed journals. Fourteen RCTs (1,379 participants, 42% in one RCT) met the selection criteria. The findings relevant to EEG biofeedback state EEG biofeedback was superior to no treatment (one RCT), and treatment with EEG biofeedback led to better results on an intelligence test than did a waiting-list control (one RCT).
In a replication of a previous study (Rossiter & La Vaque, 1995), Rossiter (2004) reports on a study with a larger sample, expanded age range, and improved statistical analysis. Thirty-one ADHD patients who chose stimulant drug treatment were matched with 31 patients who chose an EEG
biofeedback treatment program. EEG biofeedback patients received either office (n = 14) or home (n = 17) EEG biofeedback. Stimulants for medication patients were titrated using the (TOVA). Both groups showed statistically and clinically significant improvement on the TOVA measures of attention, impulse control, processing speed, and variability in attention. The EEG biofeedback group demonstrated statistically and clinically significant improvement on behavioral measures (Behavior Assessment System for Children and Brown Attention Deficit Disorder Scales). The TOVA Confidence interval and nonequivalence null hypothesis testing confirmed the EEG biofeedback program produced outcomes equivalent to those obtained with stimulant drugs.
To explore the effectiveness of EEG biofeedback on children with ADHD, a randomized self-controlled study with assessment taken before and after treatment was conducted (Chen et al. 2004). A total of 30 ADHD children were selected for the study from the Children’s Mental Health Clinic of Nanjing Brain Hospital. Children were treated with EEG biofeedback. The Integrated Visual and Auditory continuous performance test (IVA) was used to evaluate before treatment and after 20 and 40 treatments. Main outcome measures were the control quotient and attention quotient of the IVA. After 20 treatments, the control quotients significantly increased and continued to significantly increase after 40 treatments.
Cho et al. (2004) reported a study on the effectiveness of EEG biofeedback, along with virtual reality (VR), in reducing the level of inattention and impulsiveness. Twenty-eight male adolescents with social problems took part in this study. They were separated into three groups: a control group, a VR group, and a nonVR group. Both the VR and nonVR groups underwent eight sessions of EEG biofeedback training while the control group just waited during the same period. All participants performed a continuous performance task (CPT) before and after the complete training session. The results showed both the VR and nonVR groups (both also received EEG biofeedback training) achieved better scores in the CPT after training while the control group showed no significant difference.
Eisenberg, Ben-Daniel, Mei-Tal, and Wertman (2004) reported a study to determine the effect of a new noninvasive technique of noncognitive biofeedback called Autonomic Nervous System Biofeedback Modality on the behavioral and attention parameters of a sample of children with attention deficit hyperactivity disorder. Nineteen subjects who met DSM-IV criteria for ADHD received four sessions of Autonomic Nervous System Biofeedback Modality treatment. The heart rate variability was measured before and after the treatment, as were measures of efficacy, including Conners Teacher Questionnaires (28 items), the Child Behavior Check List for parents and teachers, and Continuous Performance Test. Positive treatment effect was observed in all the subjects. A positive correlation between heart rate variability changes and improvement of symptoms of attention deficit hyperactivity disorder was found.
Orlando and Rivera (2004) selected a number of elementary students (n=28) with identified learning problems for EEG biofeedback. Pre- and post-test reading and cognitive assessments were administered to sixth-, seventh-, and eighth-graders. Control and experimental groups were chosen at random. EEG biofeedback training was provided to the participants of the experimental group only. The control group had no treatment, just normal school-related activities. Seventeen students were assigned to each group. For various reasons, 12 finished treatment, and 14 were available for post measures in the control group. EEG biofeedback training lasted approximately 30 to 45 minutes and was conducted weekly for seven months. Some students received more sessions than others because of absences, field trips, testing, and other natural rhythms of home and school life. The average number of sessions per student was 28. EEG biofeedback was significantly more effective in improving scores on reading tests than no EEG biofeedback training. There were significant interactions between EEG biofeedback and time on basic reading, and EEG biofeedback training was more effective in improving both the verbal and full-scale IQ scores than no EEG biofeedback training. There was a significant interaction between EEG biofeedback and time on verbal IQ and on full-scale IQ. There was a trend interaction for EEG biofeedback and performance IQ, but it was not significant. The results support the hypothesis that biofeedback training is effective in improving reading quotients and IQ in LD children.
In a study by Hanslmayr, Sauseng, Doppelmayr, Schabus, and Klimesch (2005), increasing upper alpha power while lowering theta in eight sessions improved cognitive functioning as measured by a mental rotation task performed before and after training. Only those subjects who were able to increase their upper alpha power performed better. Training success (extent of EEG biofeedback training–induced increase in upper alpha power) was positively correlated with the improvement in cognitive performance and significant increase in reference upper alpha power.
Fleischman and Othmer (2005) reported a case study of mildly developmentally delayed twins. They observed improvements in IQ scores and maintenance of the gains following EEG biofeedback. Full-scale IQ scores increased 22 and 23 points after treatment and were maintained at three follow-up retests over a 52-month period. ADHD symptom checklists completed by their mother showed a similar pattern of improvement and maintenance of gains.
Jacobs (2005) describes the application of EEG biofeedback with two children who manifested multiple diagnoses, including learning disabilities (LD), ADHD, social deficits, mood disorders, and pervasive developmental disorder (PDD). Both boys had adjusted poorly to school, family, and peers. They received individualized protocols based on their symptoms and functional impairments. They were administered semiweekly 20-minute sessions of one-channel EEG biofeedback training for approximately six months. In both cases, symptoms were identified and tracked with a parent rating scale and one case with the Symptom Assessment-45 questionnaire (SA-45) also. Each boy improved in all tracked symptoms without adverse effects.
A series of three studies by Li and collegues are reported below: Li, Wu, & Chang, (2003) investigated the therapeutic effect of EEG biofeedback for ADHD. Sixty children aged six to 10 years were selected (30 children with attention deficit associated with hyperkinetic syndrome in the experimental group; 30 healthy children in the control group). The EEG recorded from the experiment group was significantly different from the control group. There was no significant difference in EEG between male and female children. Ten children received EEG biofeedback training and showed brain function was improved.
In a second study by Li and Yu-Feng (2005), ADHD children with comorbid tic disorder (n=14) received EEG biofeedback treatment (average 34 sessions). The outcome was evaluated with a variety of outcome measures before and after treatment. Significant reductions in multiple symptoms were reported. Tic symptoms were greatly reduced in all but two children who also had Tourette’s syndrome.
In the third study (Li, Tang, et al. 2005), 113 outpatient children (88 male and 25 female, mean age of 10 ± three years) from the Psychology Hyperactivity Department of the Central Hospital of Anshan City were selected. Inclusion criteria were from six to 14 years of age. Exclusion criteria were nervous system organic diseases, pervasive developmental disorder (PDD), mental retardation, epilepsy, psychotic disorder, and acoustical and visual abnormalities. ADHD children were diagnosed, and then the EEG diagnostic accuracy was calculated. The diagnostic sensitivity of EEG on ADHD was 83.58%, the specificity was 82.61%, and misdiagnosis was 16.4%. These results compare favorably with the diagnostic accuracy of the Intermediate Visual and Auditory test (IVA). The EEG biofeedback system was also used for EEG biofeedback with 27 ADHD children. Conners Parent Symptom Questionnaire was used to assess pre- and post-hyperactivity levels. There was a significant difference between the EEG values before and after treatment, and the hyperactivity indexscores were significantly declined from pre-treatment to post-treatment.
A study by Pop-Jordanova, Markovska-Simoska and Zorcec (2005) comprised 12 children of both sexes diagnosed as ADHD with the mean age of nine and a half years (seven to 13 years old). Each participated in a five-month program of EEG biofeedback training performed twice weekly. Post-treatment results showed improved EEG patterns expressed in increased 16-20 Hz (beta) activity and decreased 4-8 Hz (theta) activity. In parallel, higher scores on WISC-R, better school notes, and improved social adaptability and self-esteem were obtained.
A report by Putman, Othmer, Othmer, and Pollock (2005) that used the TOVA as the outcome measure was divided into three categories: a) primarily attentional deficits (n=12), b) primarily psychological complaints (n=20), and c) both (n=12).Participants were 44 males and females, six to 62 years old, who underwent treatment for a variety of clinical complaints. The TOVA was administered prior to EEG biofeedback training and 20 to 25 sessions thereafter. After EEG biofeedback training, significant improvements on omission, commission, and variability were observed. There was no change in reaction time. Reaction time was predominantly in the normal rangefor this population and remained unchanged following training.
Functional magnetic resonance imaging (fMRI) was used by Beauregard and Levesque (2006) to measure the effect of EEG biofeedback training in ADHD children. Twenty unmedicated ADHD children participated. Fifteen children were randomly assigned to the group trained to enhance the amplitude of the SMR (12-15 Hz) and beta 1 activity (15-18 Hz) and to decrease the amplitude of theta activity (4-7 Hz); whereas, the other five children were randomly assigned to the no-treatment group. Both groups were scanned one week before the beginning of EEG biofeedback and one week after the end of EEG biofeedback while they performed a “Counting Stroop” task and a Go/No Go task. Changes were noted in severalsubcortical areas after biofeedback treatment in the EEG biofeedback group but not in the control group. These results suggest EEG biofeedback has the capacity to functionally normalize the brain systems mediating selective attention and response inhibition in ADHD children.
A study reported by Zhang, Zhang, and Jin (2006) compared EEG biofeedback with methylphenidate in ADHD children who were treated at the Department of Child Health Care, Xinhua Hospital. Participants were randomly assigned to groups. The EEG biofeedback group received treatments of reinforcing 16-20 Hz and suppressing 4-8 Hz; EEG biofeedback treatment was provided three to five times per week continuously for three months, totaling 35 to 40 sessions. The children in the medication group were treated with methylphenidate every morning. The dose started at 5 mg and increased gradually with the patients’ conditions until the effects were satisfied without any adverse effect. The Conners Parent Rating Scale was utilized to assess the behavioral changes. The children in the EEG biofeedback group and medication group were evaluated at pre-treatment, post-treatment and one, three, and six months of follow ups. Forty children who received EEG biofeedback and 16 who received medication were involved in the result analysis. Half the children who received EEG biofeedback were those who did not respond to medication after at least three months, so EEG biofeedback was provided. After treatment, the EEG biofeedback group demonstrated significant decreases in scores on all factors of the Conners Parent Rating Scale comparedto those at pretreatment and remained stable during a six-month follow up. The medication group also showed significant decreases in scores of all factors except psychosomatic disorder and anxiety compared with those at pretreatment. The scores of psychosomatic disorder and anxiety were significantly lower in the EEG biofeedback group than in the medication group at post-treatment.
In a controlled study of effectiveness of EEG biofeedback training on children with ADHD, Zhong-Gui, Hai-Qing, and Shu-Hua (2006) reported EEG biofeedback training was applied for 30 minutes, two times per week for 40 sessions. The IVA was adopted to evaluate the effectiveness of EEG biofeedback training. The results from 60 children indicated the overall indexes of IVA were significantly improved.
In a study by Kropotov et al. (2007), it was reported that changes in EEG spectrograms, event-related potentials, and event-related desynchronisation were induced by relative beta training in ADHD children. EEG, ERPs, and event-related synchronization/desynchronization (ERD/ERS) were recorded and computed in an auditory Go/No Go task before and after 15 to 22 sessions of EEG biofeedback.
This study (Leins et al. 2007) compared EEG biofeedback training of theta-beta frequencies and training of slow cortical potentials (SCPs). SCP participants were trained to produce positive and negative SCP shifts while the theta/beta participants were trained to suppress theta while increasing beta. Participants were blind to group assignment. Each group comprised 19 children with ADHD (aged eight to 13 years). Both groups were able to intentionally regulate cortical activity and improved in attention and IQ. Parents and teachers reported significant behavioral and cognitive improvements. Clinical effects for both groups remained stable six months after treatment. Groups did not differ in behavioral or cognitive outcome.
Twenty studies were identified for treatment of ADHD with EEG biofeedback, and of those, seven were determined to have acceptable methodologies while 13 had marginal methodologies. The clinical outcome of these EEG biofeedback studies was positive for 18, inconclusive for one, and negative for one.
In another review, Fox, Tharp, and Fox (2005) reported that, in the last 30 years, multiple studies have consistently shown differences between ADHD children and non ADHD children in that the ADHD children have a surplus of slow-wave activity, mostly in the delta and theta bands, and deficiencies in the alpha and beta bands. They state that 70 to 80% of ADHD children respond favorably to stimulant medication, 35% respond favorably to placebo, and 25 to 40% do not respond favorably to medication. However, multiple studies have shown when stimulant medication is withdrawn, the improvements seen during medication usage in the medication responders are no longer maintained. In a summary of five EEG biofeedback outcome studies, they reported consistent improvements in behavior, IQ, and rating scales comparable to medication usage, and only those trained in biofeedback maintained their improvements when the treatment was withdrawn.
In a review, Loo and Barkley (2005) report EEG measures have been used to study brain processes in children with ADHD for more than 30 years, and this research supports the EEG differences between ADHD and nonADHD children. The differences are primarily in the frontal and central areas with theta activity being more abundant and beta activity less abundant; therefore, the theta-beta ratio is consistently and diagnostically larger in ADHD than non ADHD children. They report evidence of a possible percentage of ADHD subtypes for which the EEG activity described above does not fit, and a number of these individuals seem to be between 10 and 20% of all ADHD children.
Thompson and Thompson (2005) report these subtypes show distinctively different EEG patterns with an abundance of high-frequency beta. The reviewers report that, more recently, EEG biofeedback has been used, not only in research to describe and quantify underlying neurophysiology of ADHD but also clinically in the assessment, diagnosis, and treatment of ADHD. For the treatment of ADHD with EEG biofeedback, they reported mixed results based on one study from an unpublished presentation at the American Psychological Association meeting in 1994 (so methodology and outcome assessment techniques cannot be determined) and three controlled studies. Of these three studies, one had a single-case design that was inappropriate for a treatment such as EEG biofeedback, which has a demonstrated carry-over effect. The two others demonstrated positive outcomes but were dismissed on what were viewed as weak methodical grounds because the studies did not use methodologies typically associated with pharmaceutical studies but used procedures usually associated with acceptable behavioral outcome studies.
In a series of review articles (Monastra, 2005; Monastra et al. 2005; Monastra et al. 2006), the authors report, in the past three decades, EEG biofeedback has emerged as a nonpharmacologic treatment for ADHD. These articles present imaging and EEG findings that support the theory of cortical hypoarousal, especially in the central and frontal regions of the cortex and that this intervention was derived from operant conditioning studies. These conditioning studies have demonstrated the capacity for neurophysiologic training in both humans and other mammals and targets atypical patterns of cortical activation that have been identified consistently in neuroimaging and quantitative EEG studies. The research findings published to date from case studies and controlled clinical outcome studies have reported increased cortical activation on quantitative electroencephalographic examination, improved attention and behavioral control, gains on tests of intelligence, improvement on self- and other rating scales, improved CPTs, and academic achievement. Three standard protocols of SMR enhancement and beta reduction, theta enhancement and beta reduction, and SMR enhancement and beta reduction are also presented.
The effect of ROSHI protocol and cranial electrotherapy stimulation on a nine-year-old anxious, dyslexic male with attention deficit disorder was studied by Overcash (2005). Psychological testing was administered, and QEEGs were recorded before and after treatment intervention. The patient was treated using the ROSHI Complex Adaptive Protocol, Cranial Electrotherapy Stimulation, and the Project Read Reading Program. This multimodal treatment lasted six months with follow-up testing administered 15 months after initial diagnostic testing. Before and after, objective psychological test results and QEEG changes indicate significant improvement in reading, math, and spelling achievement and significant reduction in anxiety and ADD symptoms.
Mize (2004) reported a single case study of hemoencephalography (HEG) with a 12-year-old male who had a well-established diagnosis of ADHD. He was performing well in school on Concerta 36 mg at 7am and Ritalin 5 mg at 4pm. Off medication, he had significant abnormalities on IVA testing (attention quotient or AQ = 78) and in the QEEG. IVA and clinical status measurements were made before and after 10 sessions. Following the 10 sessions, the participant was tested off medication and showed a normal QEEG with improved Z scores for relative power and a normal IVA (AQ = 99.75). These results persisted in an 18-month follow up. His medication was lowered to Focalin 2.5 mg twice daily.
In a study designed to test the effectiveness of self-regulation of slow cortical potentials in children with ADHD (Strehl et al. 2006), 23 children with ADHD aged between eight and 13 years received 30 sessions of self-regulation training of slow cortical potentials in three phases of 10 sessions each. Feedback was provided while increasing and decreasing slow cortical potentials at central brain regions. Measurement before and after the trials showed that children with ADHD learned to regulate negative slow cortical potentials. After training, significant improvement in behavior, attention, and IQ score were observed. All changes proved to be stable at six months’ follow up after the end of training.
Clinical outcome was predicted by the ability to produce negative potential shifts in transfer sessions without feedback. In summary, based on these studies and the reviews, EEG biofeedback has typically been shown to be superior to control conditions and equivalent to other treatments such as stimulant medication.
The utilization of EEG biofeedback measures to facilitate diagnostic determination and protocol determination is strongly supported. Because the EEG protocols vary widely in specific bandwidths and thresholds selection, it is prudent for the practioner to know the literature to determine which specific settings to use for each client. In addition to the EEG assessment, multiple assessments, including psychological, family, and medical history; a clinical interview; and standardized assessments, such as a continuous performance test and ratings scales, should be used to formulate a comprehensive treatment plan. EEG biofeedback techniques other than those focused on EEG patterns are also under development. Further studies are needed to examine long-term effects of training sessions and whether or not refresher sessions are needed to maintain the effects.
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